Posttraumatic Stress Disorders, PTSD
Conditions
Keywords
Cognitive Behavior Therapy, Children, Pharmacotherapy
Brief summary
The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.
Detailed description
While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up assessment.
Interventions
DRUGD-cycloserine
D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
DRUGPlacebo pill
Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
BEHAVIORALCBT
12-session CBT protocol, called Youth PTSD Treatment.
Sponsors
National Institute of Mental Health (NIMH)
Tulane University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Certain number of PTSD symptoms plus functional impairment * Must be able to swallow pills
Exclusion criteria
* Serious kidney or liver disease * Epilepsy * Bipolar * Psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child PTSD Symptom Scale (CPSS) | After 12 therapy sessions, up to 28 weeks. | The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| D-cycloserine Plus CBT Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. | 17 |
| Placebo Plus CBT Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | D-cycloserine Plus CBT | Placebo Plus CBT | Total |
|---|---|---|---|
| Age, Continuous | 10.1 years STANDARD_DEVIATION 1.8 | 10.2 years STANDARD_DEVIATION 1.9 | 10.1 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 17 | 6 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Child PTSD Symptom Scale (CPSS)
The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).
Time frame: After 12 therapy sessions, up to 28 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D-cycloserine Plus CBT | Child PTSD Symptom Scale (CPSS) | 15.1 units on a scale | Standard Deviation 13.9 |
| Placebo Plus CBT | Child PTSD Symptom Scale (CPSS) | 8.9 units on a scale | Standard Deviation 7.6 |